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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K121712
Device Name AIRSTRIP RPM FOR LIFENET CONSULT
Applicant
Airstrip Technologies, Inc.
335 E. Sonterra Blvd., Suite #200
San Antonio,  TX  78258
Applicant Contact ROBERT A MILLER
Correspondent
Airstrip Technologies, Inc.
335 E. Sonterra Blvd., Suite #200
San Antonio,  TX  78258
Correspondent Contact ROBERT A MILLER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/11/2012
Decision Date 11/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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